Manager - Regulatory Affairs Pharmacist

Private Advertiser; Hong Kong; On-site; HKD 600,000 - 1,000,000; Full time

Benefits offered by this job

5 Day Work per week

Bank Holidays

12 Days Annual Leave

Performance Based Bonus

Medical Compensation plan

Staff Purchase Discount

Rapid growth opportunities to higher领导

Job summary

Julius Chen & Company (HK) Ltd in Kwai Chung is seeking a Manager- Regulatory Affairs Pharmacist to lead the regulatory team, manage new product registrations, and ensure timely compliance. The role requires precise dossier preparation, DOH liaison, and oversight of tender and QA processes.

The ideal candidate has HK registration, 2+ years of regulatory pharma experience, strong English/Chinese communication, and is ready for immediate start. Benefits and growth opportunities accompany this role.

Qualifications

• Registered pharmacist in Hong Kong with a valid Practising Certificate issued by The Pharmacy and Poisons Council of Hong Kong.
• Preferably 2 or more years of regulatory experience in pharma industry.
• Experience in registration of medicinal products.
• Basic knowledge in pharmacovigilance; QA would be an added advantage.
• Experience in negotiating with regulatory authorities would be an advantage.
• Good communication skills, fluent in written and spoken English & Chinese.
• Attention to details and able to work with limited supervision.
• Immediately available is preferable.

Responsibilities

• Lead the Regulatory Team to ensure good quality dossiers of new products submission.
• Provide effective follow-up and guidance for: new product registrations, variations, renewals and compliance maintenance.
• Liaise with DOH officer to enable earlier marketing authorization approval.
• Provide 2nd packaging operation supervision.
• Managing complaints, recall procedures and assisting to compile CAPA measures.
• Maintain well organized records, Drug Certificates, product registered particulars database.
• Liaise with overseas manufacturers to provide guidance on quality dossiers and reply to DOH inquiries.
• Tender Affairs: assess landscape, prepare quotations & time schedules for on-time submission; monitor tender logistics.

Skills

Regulatory affairs

Tender affairs

Communication

Pharmacovigilance

QA knowledge

Negotiation with authorities

Education

Registered pharmacist in Hong Kong

Job description

Interested in this role? Call 94989342 to find out more.

Julius Chen & Company (HK) Ltd
Since the inception of our company in 1987, we begin our business in Generic Pharmaceutical distribution by representing pharmaceutical manufacturers from the U.S.A., Europe and Asian continent. We have well positioned a distinct presence in numerous therapeutic segments of generic pharmaceuticals. After more than three decades of hard work, we have earned widespread recognition from local Medical Practitioner, Pharmacists, Chain-stores group, Drug Stores and Distributors, and have played a key role as a reliable source and supplier of broad range health care products including: Pharmaceuticals, Nutraceuticals, Cosmeceuticals, Traditional Chinese Medicines, Pesticides & Insecticides as well as Medical Device products.
To strengthen our market share in Hong Kong and Macau, we continue to invest vigorously in upgrading our facilities, developing more innovative products, and adding more talented employee to our team. We always seek for new opportunity and are prepared to cope with highly competitive and ever changing market demand.

Manager- Regulatory Affairs Pharmacist

A well-established pharmaceutical and health care supplement importer/ marketer in Kwai Chung. Invite high caliber candidate, and who enthuses to achieve a high level career position to join the expanding company.

RESPONSIBILITY :

Regulatory Affairs :

• Lead the Regulatory Team to ensure good quality dossiers of new products submission. Provide effective follow-up and guidance for :
  • New product registrations application.
  • Variations and post-approval changes
  • Renewals and compliance maintenance
• Liaise with DOH officer to enable earlier marketing authorization approval.
• Provide 2nd packaging operation supervision.
• Managing complaints, recall procedures and assisting to compile CAPA (Corrective and Preventive) measures.
• Maintain well organized records, Drug Certificates, product registered particulars database.
• Liaise with overseas manufacturers to provide guidance on quality dossiers. Assist overseas RA officer to provide appropriate reply to DOH enquiries.
• Tender Affairs:
  • Assess Tender Landscape, policy and regulatory requirements
  • Assist in preparing the quotations, tender documents & time schedules for on-time submission of tender application
  • Monitor of tender logistic and orders performance and other tender related affairs.

Requirements

• · Registered pharmacist in Hong Kong with a valid Practising Certificate issued by The Pharmacy and Poisons Council of Hong Kong
• Preferably 2 or more years of regulatory experience in pharma industry.
• Experience in registration of medicinal products
• Basic knowledge in pharmacovigilance, QA would be an added advantage.
• Experience in negotiating with regulatory authorities would be an advantage.
• Good communication skills, fluent in written and spoken English & Chinese.
• Attention to details and able to work with limited supervision.
• Immediately available ispreferable

Benefits:

• 5 Day Work per week.
• Bank Holidays
• 12 Days Annual Leave
• Performance Based Bonus
• Medical Compensation plan.
• Staff Purchase Discount
• Rapid growth opportunities to higher leadership position for strong performers.

For more information, contact us on 94989342 .